Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Authorised, recruitment pending
Participants planned
76
Countries
1
Sites
1
Immune Thrombocytopenia, Hematopoietic Syndrome of Acute Radiation Syndrome
Key facts
- Sponsor
- Qilu Pharmaceutical Co. Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Decision date (initial)
- 2026-01-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Immune Thrombocytopenia, Hematopoietic Syndrome of Acute Radiation Syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10043554 | Thrombocytopenia | 100000004851 |
| 20.1 | LLT | 10001037 | Acute radiation syndrome | 10022117 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Qilu Pharmaceutical Co. Ltd.
- Sponsor organisation
- Qilu Pharmaceutical Co. Ltd.
- Address
- 8888 Lvyou Road, High Tech Zone High Tech Zone
- City
- Jinan
- Postcode
- 250104
- Country
- China
Scientific contact point
- Organisation
- Qilu Pharmaceutical Co. Ltd.
- Contact name
- Heze Yu
Public contact point
- Organisation
- Qilu Pharmaceutical Co. Ltd.
- Contact name
- Heze Yu
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Authorised, recruitment pending | 76 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-30 | Poland | Acceptable 2026-01-23
|
2026-01-26 |